Inovio announces peer-reviewed data from phase 1/2 clinical trial with INO-307

Inovio (INO) announced that peer-reviewed data from its Phase 1/2 clinical trial with INO-3107 as a potential treatment for recurrent respiratory papillomatosis, or RRP, were published online in Nature Communications under the title DNA immunotherapy for recurrent respiratory papillomatosis, or RRP,: phase 1/2 study assessing efficacy, safety, and immunogenicity of INO-3107. In the trial, treatment with INO-3107 induced new populations of T cells in the blood that traveled to the airway and papilloma tissue and were correlated with a reduction in the number of post-treatment surgeries. Of the 32 patients in the trial, 26 patients, or 81%, required fewer surgeries post-treatment when compared to the year prior to treatment. INO-3107 treatment was also well tolerated in the trial. INOVIO plans to submit its biologics license application (BLA) for INO-3107 in mid-2025 and request rolling submission and priority review under the FDA’s accelerated approval program. If approved, INO-3107 would be the first DNA medicine approved for any indication in the U.S. Highlights from the Nature Communications Paper included: 81.3% of patients had a decrease of at least one surgical intervention from the prior year after INO-3107 administration, including 28.1% that required no surgical intervention (Complete Response) during or after the dosing window; the Overall Response Rate, which includes those patients who had either a Complete Response or a Partial Response was 72%.